Dietary supplements are defined under the law as products taken by mouth that contain a dietary ingredient intended to supplement the diet, according to the Food and Drug Administration. Dietary ingredients in supplements include vitamins, minerals, amino acids, botanical substances, enzymes, microbial probiotics and metabolites. The FDA has several requirements for vitamins.
Good Manufacturing Practice
The Food and Drug Administration established Good Manufacturing Practice regulations for production of vitamin supplements in 2007. Manufacturers must test and evaluate products for identity, purity, strength and composition to ensure that the product contains what is stated on the label and is not contaminated with harmful substances, such as heavy metals, pesticides and other impurities. If the product does not meet the 100 percent requirement for identity of a particular ingredient, the manufacturer must prove that less than 100 percent identity testing does not diminish the assurance that the ingredient is in fact the right ingredient. Unlike drugs, vitamin supplements do not have to be proven safe and effective before they can be sold.
Product Safety
The U.S. Congress approved the Dietary Supplement Health and Education Act of 1994, also called DSHEA, that requires manufacturers to substantiate the safety of vitamin ingredients used in making the product. Congress authorizes the FDA to take action against any unsafe vitamin supplement product that is marketed by monitoring safety literature, adverse event reports and product information that includes labeling, claims, package inserts and marketing materials. An example of the FDA enforcing DSHEA involves liquid vitamin D supplements for infants, according to the American Academy of Family Physicians. The FDA asked manufacturers to clearly and accurately mark on the droppers the level for 400 IU of liquid vitamin D or provide droppers that do not hold more than this amount because of potential overdosing.
Product Claim
DSHEA also requires manufacturers to substantiate product claims with evidence that demonstrates the claims are not false or misleading. Vitamin supplements cannot be promoted as a treatment, prevention or cure for a specific disease or condition, according to the FDA. This would be considered a drug claim. Manufacturers are allowed by law to make three types of product claims for vitamin supplements, including structure and function claims, nutrient content claims and health claims. When a manufacturer makes a structure and function claim, such as the role a vitamin plays in the body, it must also include a disclaimer that states the claim has not been evaluated by the FDA and the product does not diagnose, treat, cure or prevent a particular disease. An example of a health claim is "an inadequate intake of calcium or calcium and vitamin D contributes to low peak bone mass, which has been identified as one of many risk factors in the development of osteoporosis."
References
- Food and Drug Administration: Fortify Your Knowledge About Vitamins
- Food and Drug Administration: Backgrounder: Final Rule for Current Good Manufacturing Practices (CGMPs) for Dietary Supplements
- New York Times: FDA Approves Vitamin Rules
- American Academy of Family Physicians: FDA Issues Recommendations for Parents, Industry on Infant Vitamin D Supplements
- Food and Drug Administration: Overview of Dietary Supplements
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